FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2061822
·
Received April 4, 2011
Report
- Report Number
- 3004209178-2011-02541
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 17, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE INS WAS SUSPECTED OF BEING OVER-DISCHARGED. THERE WAS NO COMMUNICATION WITH THE PHYSICIAN OR PATIENT PROGRAMMER. PATIENT THINKS THE DEVICE WAS CHARGED, BUT MANUFACTURER'S REPRESENTATIVE WAS UNSURE IF THE INS THAT WAS ACTUALLY CHARGED OR THE RECHARGER, SINCE THERE WAS NO COMMUNICATION. PATIENT HAD BEEN RECEIVING RADIATION TREATMENTS FOR ABOUT SEVEN WEEKS AND REPRESENTATIVE IS NOT SURE IF THE PATIENT HAD NEGLECTED TO CHARGE THE DEVICE OR IF THE RADIATION MAY HAVE CAUSED THE INS TO LOCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | ACCESSORY: MODEL 37752, LOT# NKA124166N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE124884N| LEAD: MODEL 3777, LOT# V218786020| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V218786021| IMPLANTED: |